Method and apparatus for delivering drugs to the spine of a patient, and/or for delivering other materials and/or devices to the spine of a patient

ABSTRACT

A drug delivery system comprising: a plurality of needles; a needle guide for guiding and holding the plurality of needles during insertion into a patient&#39;s spine; a syringe containing a drug which is to be delivered into the patient&#39;s spine; a port multiplier comprising an inlet port connectable to the syringe and a plurality of outlet ports; and a plurality of tubes for providing fluid connections between the outlet ports of the port multiplier and the plurality of needles.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application:

-   -   (1) is a continuation-in-part of pending prior U.S.        Non-Provisional patent application Ser. No. 16/380,777, filed        Apr. 10, 2019 by Pain Away Solutions, LLC and Gabriel Garcia        Diaz for LUMBAR SYRINGE GUIDE ASSEMBLY (Attorney's Docket No.        PAIN-1), which patent application claims benefit of:        -   (A) prior U.S. Provisional Patent Application Ser. No.            62/655,666, filed Apr. 10, 2018 by Gabriel Garcia Diaz for            LUMBAR SYRINGE GUIDE ASSEMBLY (Attorney's Docket No.            GARCIA-DIAZ.G-LZ.001PP); and    -   (2) claims benefit of pending prior U.S. Provisional Patent        Application Ser. No. 62/908,717, filed Oct. 1, 2019 by Pain Away        Solutions, LLC and Gabriel Garcia Diaz et al. for METHOD AND        APPARATUS FOR DELIVERING DRUGS TO THE SPINE OF A PATIENT, AND/OR        FOR DELIVERING OTHER MATERIALS AND/OR DEVICES TO THE SPINE OF A        PATIENT (Attorney's Docket No. PAIN-02030405 PROV).

The three (3) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to drug delivery systems in general, and moreparticularly to drug delivery systems for delivering drugs to the spineof a patient. This invention also relates to delivering other materialsand/or devices to the spine of a patient. Among other things, thepresent invention comprises a system of different components which areintended to be used collectively for the purpose of delivering drugs tothe spine of a patient. However, it should also be appreciated that thedifferent components (i.e., devices) of the system may be usedindependently of one another, or may be used with other devices, or maybe used for other purposes, etc., such as utilizing the spring-loadedsyringe assist device (see below) for assisting in the delivery ofintravenous medications to patients. Also, the needle guide (see below)may be used for pedicle screw placement, with or without the use ofnavigation software, etc.

BACKGROUND OF THE INVENTION

Physicians frequently need to inject drugs into the spine of a patient,e.g., to treat patients with chronic back pain. In many cases, thespinal injection must be fluoroscope-guided to ensure that the drugs areplaced into the correct locations in the patients' anatomy. In manycases, an individual patient may need to have injections in multiplelocations within the spine.

Currently, physicians handle one needle at a time, which means that theyneed to find the correct location for each needle placement prior toinsertion of the medication of the syringe into the patient. The need tohandle each needle independently leaves room for error, particularlywhen it comes to the precision of the insertion of the needle into apatient's anatomy. Moreover, because each needle has to be handledseparately, this adds time to the procedure and, in some cases,additional radiation exposure to the patient and the healthcare staffinvolved in the care of the patient.

Therefore, there is a need for a novel drug delivery system whichassists a physician in inserting and holding in place multiple needles,while ensuring the accuracy of the insertion angles and locations of themultiple needles, and delivers medication through the multiple needlesto a patient.

SUMMARY OF THE INVENTION

The present invention relates to a method and apparatus for deliveringdrugs to the spine of a patient.

More particularly, the present invention comprises the provision and useof a novel drug delivery system which comprises a plurality of needles;a needle guide for guiding and holding the plurality of needles duringinsertion into the patient's spine; a syringe containing the drug whichis to be delivered into the patient's spine; a port multipliercomprising an inlet port and a plurality of outlet ports; and aplurality of tubes for providing a connection between the outlet portsof the port multiplier and the plurality of needles.

In use, the needle guide is positioned against the skin of the patientadjacent to the spine; the needle guide is used to guide the pluralityof needles as they are inserted into the spine and to hold them inposition; the port multiplier is connected to the syringe containing thedrug which is to be delivered; tubes are used to connect the outletports of the port multiplier to the needles; and the syringe is used toeject the drug into the port multiplier, through the tubes and throughthe needles so as to be injected into the desired locations in the spineof the patient.

The present invention may also be used for delivering other materials(e.g., non-drug fluids including biologics, etc.) and/or devices (e.g.,pedicle screws, bone implants, etc.) to the spine of a patient.

In one form of the invention, there is provided a drug delivery systemcomprising:

-   -   a plurality of needles;    -   a needle guide for guiding and holding the plurality of needles        during insertion into a patient's spine;    -   a syringe containing a drug which is to be delivered into the        patient's spine;    -   a port multiplier comprising an inlet port connectable to the        syringe and a plurality of outlet ports; and    -   a plurality of tubes for providing fluid connections between the        outlet ports of the port multiplier and the plurality of        needles.

In another form of the invention, there is provided a method fordelivering drugs, the method comprising:

-   -   providing a drug delivery system comprising:        -   a plurality of needles;        -   a needle guide for guiding and holding the plurality of            needles during insertion into a patient's spine;        -   a syringe containing a drug which is to be delivered into            the patient's spine;        -   a port multiplier comprising an inlet port connectable to            the syringe and a plurality of outlet ports; and        -   a plurality of tubes for providing fluid connections between            the outlet ports of the port multiplier and the plurality of            needles;    -   positioning the needle guide against the skin of the patient        adjacent to the spine;    -   using the needle guide to guide the plurality of needles as they        are inserted into the spine and hold them in position;    -   connecting the port multiplier to the syringe containing the        drug which is to be delivered;    -   connecting the tubes to the outlet ports of the port multiplier        and to the needles; and    -   using the syringe to eject the drug into the port multiplier,        through the tubes and through the needles so as to be injected        into the desired locations in the spine of the patient.

In another form of the invention, there is provided a delivery systemfor delivering a plurality of cannulated devices into the anatomy of apatient, the delivery system comprising:

-   -   a plurality of guidewires;    -   a frame; and    -   a plurality of guidewire supports selectively movably mounted to        the frame, wherein each of the guidewire supports is configured        to guide and hold a guidewire during insertion into the anatomy        of a patient;    -   wherein the frame comprises two frame supports connected to one        another by at least one adjustable arm;    -   wherein each of the frame supports comprises a frame lumen and a        pair of slots communicating with the frame lumen;    -   wherein each of the guidewire supports comprises:        -   a body slidably disposed in a frame lumen of a frame            support; and        -   a member configured to slidably support a guidewire and to            selectively lock the body in a selected position within a            frame lumen of a frame support.

In another form of the invention, there is provided a method fordelivering a plurality of cannulated devices into the anatomy of apatient, the method comprising:

-   -   providing a delivery system comprising:        -   a plurality of guidewires;        -   a frame; and        -   a plurality of guidewire supports selectively movably            mounted to the frame, wherein each of the guidewire supports            is configured to guide and hold a guidewire during insertion            into the anatomy of a patient;        -   wherein the frame comprises two frame supports connected to            one another by at least one adjustable arm;        -   wherein each of the frame supports comprises a frame lumen            and a pair of slots communicating with the frame lumen;        -   wherein each of the guidewire supports comprises:            -   a body slidably disposed in a frame lumen of a frame                support; and            -   a member configured to slidably support a guidewire and                to selectively lock the body in a selected position                within a frame lumen of a frame support;    -   positioning the frame against the anatomy of the patient;    -   using the plurality of guidewire supports to guide the plurality        of guidewires as they are inserted into the anatomy of the        patient;    -   withdrawing the frame and the plurality of guidewire supports        while leaving the plurality of guidewires inserted into the        anatomy of the patient; and    -   delivering a plurality of cannulated devices into the anatomy of        a patient by passing the cannulated devices over the plurality        of guidewires.

In another form of the invention, there is provided a guide for guidingand holding a plurality of objects during insertion into a patient'sbody, the guide comprising:

-   -   a frame; and    -   a plurality of object supports selectively movably mounted to        the frame, wherein each of the object supports is configured to        guide and hold an object during insertion into the patient's        body;    -   and further wherein each of the object supports is        reconfigurable between:        -   (i) a first configuration wherein the object support is            movable at least one of (a) axially along the frame and (b)            rotatably relative to the frame; and        -   (ii) a second configuration wherein the object support is            fixed relative to the frame.

In another form of the invention, there is provided a syringe assistdevice for use with a syringe, wherein the syringe comprises (a) asyringe body having a cavity and an output port, and (b) a plungermovably disposed in the cavity for driving the contents of the cavityout of the output port, the syringe assist device comprising:

-   -   a housing for mounting to the syringe body;    -   a driver for engaging the plunger and moving the plunger so as        to drive the contents of the cavity out of the output port; and    -   a power unit for moving the driver.

In another form of the invention, there is provided a port multipliercomprising:

-   -   a hollow body having an interior;    -   an input port in fluid communication with the interior of the        hollow body, the input port being configured for attachment to a        syringe; and    -   a plurality of output ports in fluid communication with the        interior of the hollow body, each of the plurality of output        ports being configured for attachment to a fluid line.

BRIEF DESCRIPTION OF THE FIGURES

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIGS. 1-8, 8A, 9, 10, 10A and 11-19 are schematic views showing onepreferred form of the present invention;

FIGS. 20 and 20A-20J are schematic views showing an alternative form ofthe needle guide;

FIG. 21 is a schematic view showing a spring-loaded syringe assistdevice which may be used with the syringe of the system of the presentinvention (and/or may be used as an independent syringe assist devicefor medication delivery to patients);

FIG. 21A is a schematic view showing an alternative form of thespring-loaded syringe assist device of FIG. 21 ; and

FIG. 22 is a schematic view showing a vial adapter which may be usedwith the system of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In one form of the invention, the present invention comprises theprovision and use of a novel drug delivery system 5 for delivering adrug to the spine of a patient.

Drug Delivery System 5 in General

In one form of the invention, and looking now at FIGS. 1-8, 8A, 9, 10,10A and 11-19 , drug delivery system 5 comprises a plurality of needles10; a needle guide 15 for guiding and holding the plurality of needlesduring insertion into the patient's spine; a syringe 20 containing thedrug which is to be delivered to the spine of the patient; a portmultiplier 25 comprising an inlet port (see below) and a plurality ofoutlet ports (see below); and a plurality of tubes 30 for providing aconnection between the outlet ports of the port multiplier and theplurality of needles.

The Plurality of Needles 10

Each of the plurality of needles 10 comprises a shaft 35 having a sharpdistal tip 40 and a hub 45. See FIG. 3 . A lumen 50 extends betweensharp distal tip 40 and hub 45. Hub 45 is configured for connection to atube 30, e.g., it may comprise a luer lock connector or anotherconnector of the sort used to connect fluid lines. Shaft 35 may bestraight or bent as appropriate.

Needle Guide 15

Needle guide 15 generally comprises a frame 55. Frame 55 preferablycomprises two parallel supports 60, which are connected to one anotherby at least one adjustable arm 65. See FIG. 8 . Each parallel support 60is hollow (i.e., it comprises an interior lumen 68, see FIG. 8A) andcomprises a distal surface 70 facing the patient and a proximal surface75 facing the surgeon. One or more slots 80 are formed in each parallelsupport 60. Slots 80 open on distal surface 70 and proximal surface 75and intersect interior lumens 68. The at least one adjustable arm 65preferably telescopes so as to allow the distance between the twoparallel supports 60 to be adjusted. Parallel supports 60 and the atleast one adjustable arm 65 are preferably radiolucent, with radiopaquemarkers 85. By way of example but not limitation, parallel supports 60and the at least one adjustable arm 65 may be formed out of plastic, andradiopaque markers 85 may comprise a metal coating disposed on parallelsupports 60.

A plurality of needle supports 90 (FIG. 8A) are adjustably mounted tointerior lumens 68 and slots 80 of parallel supports 60. Moreparticularly, each of the needle supports 90 comprises a spherical body95 slidably disposed in interior lumens 68 of parallel supports 60.Spherical bodies 95 are sized to be slightly smaller than interiorlumens 68 of parallel supports 60 so that spherical bodies 95 can slidealong interior lumens 68. At the same time, spherical bodies 95 aresized to be slightly larger than the width of slots 80 such thatspherical bodies 95 cannot pass out of slots 80. Each spherical body 95comprises a threaded bore 100. Each of the needle supports 90 alsocomprises a body 105 having a threaded projection 110 at its distal end.Threaded projection 110 is sized to extend through slots 80 of parallelsupports 60 and make a threaded engagement with threaded bore 100 ofspherical body 95. Threaded projection 110 is narrower than slots 80 sothat when threaded projection 110 is received by threaded bore 100 ofspherical body 95, and body 105 is spaced from proximal surface 75 ofparallel support 60, threaded projection 110 can pivot (on rotatingspherical body 95) relative to parallel support 60. Body 105 andthreaded projection 110 comprise a lumen 115 extending therethrough.Lumen 115 is sized to slidably receive the shaft 35 of a needle 10 so asto guide and support shaft 35 of a needle 10. Note that in analternative approach for guided delivery, needle supports 90 may bereplaced with alternative targeted supports for the guided delivery ofdevices, e.g., such as the guided delivery of pedicle screws, and/orguidewires for delivering pedicle screws, which may or may not be usedwith navigation software.

On account of the foregoing construction, when threaded projection 110is received by threaded bore 100 of spherical body 95, body 105 can be(i) spaced from proximal surface 75 of parallel support 60, whereby toallow needle support to move longitudinally along slot 80 and to pivotrelative to the longitudinal axis of parallel support 60, whereby toadjust the location and orientation of lumen 115 of a needle support 90,and (ii) brought into engagement with proximal surface 75 of parallelsupport 60, whereby to lock needle support 90 in position in slot 80 soas to prevent longitudinal movement of needle support 90 and to preventpivotal movement of needle support 90 relative to the longitudinal axisof parallel support 60, whereby to fix the location and orientation oflumen 115 of a needle support 90.

In one preferred form of the invention, parallel supports 60 arepreferably formed out of two halves 60A, 60B which may be joinedtogether during manufacture, such that spherical bodies 95 of needlesupports 90 may be loaded into interior lumens 68 of parallel supports60 before halves 60A, 60B are joined together.

If desired, needle supports 90 may be formed out of radiolucentmaterials and, if desired, a radiopaque marker may be disposed on aportion of needle supports 90 to assist in targeting needle supports 90(e.g., a radiopaque marker may be disposed on the distal end of threadedprojection 110).

Syringe 20

Syringe 20 may comprise a standard syringe, e.g., a hollow body 120having an outlet port 125 and a plunger 130 slidably received in hollowbody 120. See FIG. 11 . The drug to be delivered to the spine isdisposed within hollow body 120, such that distal movement of plunger130 causes the drug to be ejected out of outlet port 125.

Port Multiplier 25

Port multiplier 25 preferably comprises a hollow body 135 having asingle inlet port 140 and a plurality of outlet ports 145, such that afluid injected into inlet port 140 will be directed out the plurality ofoutlet ports 145. See FIG. 16 . Caps 150 may be provided for selectivelyclosing off individual ones of outlet ports 145. Alternatively and/oradditionally, valves 152 may be provided in outlet ports 145 forselectively closing off individual ones of outlet ports 145.

The Plurality of Tubes 30

Each of the plurality of tubes 30 comprises a flexible hollow tubularbody 155 having a needle connector 160 at one end for connecting withhub 45 of needle 10 (see FIG. 19 ), and a port multiplier connector 165at the other end for connecting to an outlet port 145 of port multiplier25 (see FIG. 12 ).

Needles 10 being Pre-Fixed to Tubes 30 and/or Tubes 30 being Pre-Fixedto Port Multiplier 25

Note that, if desired, needles 10 may be pre-fixed to tubes 30, and/ortubes 30 may be pre-fixed to outlet ports 145 of port multiplier 25.

Use of Drug Delivery System 5

In use, needle guide 15 is positioned against the skin of the patientadjacent to the spine; needle guide 15 is adjusted so that it can guidethe plurality of needles 10 as they are inserted into the spine and holdthem in position; port multiplier 25 is connected to syringe 20containing the drug which is to be delivered; tubes 30 are used toconnect the outlet ports 145 of port multiplier 25 to the needles 10;and the syringe 20 is used to eject the drug into port multiplier 25,through tubes 30 and through needles 10 so as to be injected into thedesired locations in the spine of the patient.

More particularly, in one preferred form of the invention, drug deliverysystem 5 may be used as follows.

First, needle guide 15 is positioned against the skin of the patientadjacent to the spine. Adjustable arm 65 is adjusted as necessary so asto position the two parallel supports 60 on either side of the patient'sspine. If necessary, frame 55 may be secured to the patient, e.g., withtape, a Velcro strap, etc.

Next, needle guide 15 is used to guide a plurality of needles 10 as theyare inserted into the spine and to hold the needles in position. Thismay be done by loosening a body 105 of a needle support 90 relative tothe corresponding spherical body 95 of that needle support 90, slidingthe needle support 90 along a slot 80 and adjusting its angular positionas necessary, and then advancing a needle 10 through lumen 115 of theneedle support 90 so as to advance the needle 10 to the desiredlocation. Preferably this is done using fluoroscopic guidance (e.g.,with a needle support in its “loosened” condition, a needle is advancedthrough the needle support and its position checked using fluoroscopy;if necessary, the needle may be withdrawn and repositioned, until theneedle is in its proper position). When needle 10 is properly positionedin the spine, body 105 may be screwed down so as to securely engageparallel support 60, whereby to lock needle support 90 from longitudinaland pivotal motion, thereby keeping needle 10 in proper position. Theforegoing process is then repeated for additional needle supports 90 andneedles 10 until an appropriate number of needles 10 are properlypositioned.

Then inlet port 140 of port multiplier 25 is connected to outlet port125 of syringe 20 which contains the drug which is to be delivered.

Tubes 30 are then connected to outlet ports 145 of port multiplier 25and to hubs 45 of needles 10.

Then syringe 20 is used to flow the drug into port multiplier 25,through tubes 30 and through needles 10 so as to be injected into thedesired locations in the spine.

Alternative Needle Guide

If desired, needle supports 90 may comprise an alternative construction.More particularly, in this form of the invention, and looking now atFIGS. 20 and 20A-20J, needle supports 90A may be provided. Needlesupports 90A generally comprise a tubular body 95A for slidablepositioning within lumens 68 of parallel supports 60. Tubular body 95Acomprises diametrically-opposed openings 100A. Needle supports 90A alsocomprise a tapered body 105A for selected disposition in openings 100Aof tubular body 95A. Tapered body 105A comprises a lumen 115A.

In this form of the invention, when needle supports 90A are to bemovably disposed in lumens 68, tapered body 105A is lightly positionedin openings 100A so as to cause nominal expansion of tubular body 95A.When needle supports are to be locked in position in lumens 68 ofparallel supports 60, tapered body 105A is forced distally, whereby todilate openings 100A and thereby enlarge tubular body 95A, whereby tolock tubular body 95A within lumens 68 of parallel supports 60. Notethat tubular bodies 95A extend through slots 80 in parallel supports 60,and needles 10 extend through lumens 115A of tapered bodies 105A.

If desired, needle supports 90A may be formed out of radiolucentmaterials and, if desired, a radiopaque marker may be disposed on aportion of needle supports 90A to assist in targeting needle supports90A (e.g., a radiopaque marker may be disposed on the distal end oftapered body 105A).

Spring-Loaded Syringe Assist Device

In another form of the invention, and looking now at FIG. 21 , aspring-loaded syringe assist device 170 may be provided to power distalmovement of plunger 130 of syringe 20. More particularly, in this formof the invention, spring-loaded syringe assist device 170 comprises anassist plunger 175 which engages plunger 130 of syringe. Assist plunger175 is powered by a spring 180. An actuator safety lock 185 is providedto prevent assist plunger 175 from moving under the influence of spring180 until actuator safety lock 185 is removed.

In this form of the invention, in use, spring-loaded syringe assistdevice 170 is mounted to the proximal end of syringe 20 so that assistplunger 175 engages plunger 130 of syringe 20, and then, when the drugis to be deployed, actuator safety lock 185 is removed, whereupon spring180 causes assist plunger 175 of spring-loaded syringe assist device 170to drive plunger 130 of syringe 20 distally, whereby to dispense thedrug in syringe 20.

If desired, and looking now at FIG. 21A, spring-loaded syringe assistdevice 170 may be provided with a brake lever 186 for increased controlof dispensing the drug in syringe 20.

More particularly, brake lever 186 comprises a spring arm 187 whichnormally holds a finger 188 in engagement with teeth 175A on assistplunger 175 of spring-loaded syringe assist device 170, whereby to lockassist plunger 175 against axial movement. Squeezing spring arm 187(e.g., between the thumb and forefinger of a user) withdraws finger 188from engagement with teeth 175A on assist plunger 175, whereby to enableassist plunger 175 to move axially under the power of the aforementionedspring 180.

In use, spring-loaded syringe assist device 170 is mounted to syringe 20by positioning the finger grips of the syringe in slots 189 at the baseof spring-loaded syringe assist device 170 with plunger 130 of syringe20 being disposed within the body of spring-loaded syringe assist device170, adjacent to the distal end of assist plunger 175. When the drug isto be dispensed from syringe 20, spring arm 188 is squeezed so as towithdraw finger 188 from engagement with teeth 175A of assist plunger175, whereby to “unlock” assist plunger 175 of spring-loaded syringeassist device 170 so that assist plunger 175 can move distally under thepower of spring 180, whereby to dispense the drug in syringe 20. Whenthe desired amount of the drug has been dispensed, spring arm 187 isreleased so as to cause finger 188 to re-engage teeth 175A of assistplunger 175, whereby to “lock” assist plunger 175 of spring-loadedsyringe assist device 170 from further distal movement under the powerof spring 180. If and when additional drug is to be dispensed fromsyringe 20, spring arm 188 is squeezed again so as to withdraw finger188 from engagement with teeth 175A of assist plunger 175, whereby to“unlock” assist plunger 175 of spring-loaded syringe assist device 170so that assist plunger 175 can move distally under the power of spring180, whereby to dispense the drug in syringe 20. When an appropriateamount of the drug has been dispensed, spring arm 187 is released so asto “lock” assist plunger 175 against further movement.

It should also be appreciated that, if desired, the spring 180 ofspring-loaded syringe assist device 170 may be replaced by a poweredmechanism, e.g., an electrical motor.

Filling Syringe 20

In many cases, syringe 20 may be pre-filled with the drug which is to beinjected into the spine. However, if desired, syringe 20 may be filledat the time of use. In this case, and looking now at FIG. 22 , it can bedesirable to interpose a vial adapter 190 between the outlet port 125 ofsyringe 20 and inlet port 140 of port multiplier 25. Vial adapter 190preferably comprises a T-shaped hollow body 195 having a first port 200connectable to the outlet port 125 of syringe 20, a second port 205connectable to the inlet port 140 of port multiplier 25, and a needleline 210 connectable to a vial 215. A check valve 220 is provided inT-shaped hollow body 195 at second port 205, and a check valve 225 isprovided in T-shaped hollow body 195 at needle line 210. Check valve 220allows fluid to flow from T-shaped hollow body 195 to port multiplier 25but prevents fluid from flowing from port multiplier 25 into T-shapedhollow body 195. Check valve 225 allows fluid to flow from needle line210 into T-shaped hollow body 195 but prevents fluid from flowing fromT-shaped hollow body 195 into needle line 210.

When syringe 20 is to be loaded from vial 215, plunger 130 is drawnproximally so as to create suction at outlet port 125 of syringe 20.Check valve 225 allows the drug in vial 215 to be drawn into syringe 20,with check valve 220 preventing air from passing out of port multiplier25 and into syringe 20. When the drug is to be dispensed from syringe20, plunger 130 is moved distally. When this occurs, check valve 220prevents the drug exiting outlet port 125 of syringe from re-enteringneedle line 210, and check valve 225 allows the drug to pass into portmultiplier 25.

Use of the System to Deliver Other Materials

In the foregoing disclosure, the system of the present invention isdiscussed in the context of delivering drugs (e.g., analgesics) to thespine of the patient. However, it should be appreciated that the presentinvention may also be used for delivering other materials (e.g.,non-drug fluids including biologics, etc.) to the spine of a patient.

Use of Needle Guide 15 for Deploying Other Objects into the Body of aPatient

It should be appreciated that the present invention may also be used inmedical procedures which require targeted deployment of objects into thespine or other anatomy of a patient.

By way of example but not limitation, needle guide 15 may be used todeploy pedicle screws into the spine of a patient. More particularly, inthis form of the invention, needle guide 15 may be used, withfluoroscopic imaging, or navigation software, to set a plurality ofguidewires into the pedicles of the spine. Once one or more guidewireshave been targeted into the pedicles of the spine using needle guide 15,the needle guide may be removed and then pedicle screws may be moveddown the guidewires and advanced into the pedicles of the spine.

By way of further example but not limitation, needle guide 15 may beused to deploy bone implants into the spine of a patient.

By way of still further example but not limitation, needle guide 15 maybe used to deploy radiofrequency (RF) ablation probes into the spine ofa patient for the targeted ablation of tissue.

And by way of further example but not limitation, needle guide 15 can beused to deploy sensory nerve stimulator (SNS) leads into the spine of apatient for the targeted application of pain-relieving electricalstimulation.

It will be appreciated by those skilled in the art that the presentinvention may also be used in many other situations which requiretargeted deployment of objects into the anatomy of a patient.

Needle Supports 90 with Reduced Degrees of Freedom

In the foregoing sections, needle supports 90 are disclosed as being, intheir unlocked configuration, axially movable along parallel supports 60and rotationally movable about the longitudinal axes of parallelsupports 60. However, it should be appreciated that, if desired, needlesupports 90 may be provided with reduced degrees of freedom.

By way of example but not limitation, needle supports 90 may beconfigured so that, in their unlocked configuration, needle supports 90are axially movable along parallel supports 60 but not rotationallymovable about the longitudinal axes of parallel supports 60.

By way of further example but not limitation, needle supports 90 may beconfigured so that, in their unlocked configuration, needle supports 90are rotationally movable about the longitudinal axes of parallelsupports 60 but not axially movable along parallel supports 60.

By way of still further example but not limitation, needle supports 90may be axially and rotationally fixed relative to parallel supports 60.

It should be further appreciated that various means may be used to mountneedle supports 90 to parallel supports 60, e.g., screw mounts, clampmounts, press fit mounts, glide fit mounts, magnetic mounts, etc.

Use of the System in the Veterinary Space

While the primary application for the novel delivery system of thepresent invention is intended to be for human use, it should also beappreciated that the novel delivery system may also be used inveterinary applications.

Modifications of the Preferred Embodiments

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

1. A drug delivery system comprising: a plurality of needles; a needleguide for guiding and holding the plurality of needles during insertioninto a patient's spine; a syringe containing a drug which is to bedelivered into the patient's spine; a port multiplier comprising aninlet port connectable to the syringe and a plurality of outlet ports;and a plurality of tubes for providing fluid connections between theoutlet ports of the port multiplier and the plurality of needles.
 2. Adrug delivery system according to claim 1 wherein the needle guidecomprises: a frame; and a plurality of needle supports selectivelymovably mounted to the frame, wherein each of the needle supports isconfigured to guide and hold a needle during insertion into thepatient's spine.
 3. A drug delivery system according to claim 2 whereineach of the needle supports is reconfigurable between (i) a firstconfiguration wherein the needle support is movable axially along theframe and rotatable relative to the frame; and (ii) a secondconfiguration wherein the needle support is axially and rotatably fixedrelative to the frame.
 4. A drug delivery system according to claim 3wherein the frame comprises two frame supports connected to one anotherby at least one adjustable arm.
 5. A drug delivery system according toclaim 4 wherein each of the frame supports comprises a frame lumen and apair of slots communicating with the frame lumen.
 6. (canceled) 7.(canceled)
 8. A drug delivery system according to claim 4 wherein theframe supports are formed out of a radiolucent material, and furtherwherein radiopaque markers are disposed on the frame supports.
 9. A drugdelivery system according to claim 2 wherein the plurality of needlesupports are formed out of a radiolucent material, and further whereinradiopaque markers are disposed on the plurality of needle supports. 10.A drug delivery system according to claim 1 further comprising aspring-loaded syringe assist device for operating the syringe.
 11. Amethod for delivering drugs, the method comprising: providing a drugdelivery system comprising: a plurality of needles; a needle guide forguiding and holding the plurality of needles during insertion into apatient's spine; a syringe containing a drug which is to be deliveredinto the patient's spine; a port multiplier comprising an inlet portconnectable to the syringe and a plurality of outlet ports; and aplurality of tubes for providing fluid connections between the outletports of the port multiplier and the plurality of needles; positioningthe needle guide against the skin of the patient adjacent to the spine;using the needle guide to guide the plurality of needles as they areinserted into the spine and hold them in position; connecting the portmultiplier to the syringe containing the drug which is to be delivered;connecting the tubes to the outlet ports of the port multiplier and tothe needles; and using the syringe to eject the drug into the portmultiplier, through the tubes and through the needles so as to beinjected into the desired locations in the spine of the patient.
 12. Amethod according to claim 11 wherein the needle guide comprises: aframe; and a plurality of needle supports selectively movably mounted tothe frame, wherein each of the needle supports is configured to guideand hold a needle during insertion into the patient's spine.
 13. Amethod according to claim 12 wherein each of the needle supports isreconfigurable between (i) a first configuration wherein the needlesupport is movable axially along the frame and rotatable relative to theframe; and (ii) a second configuration wherein the needle support isaxially and rotatably fixed relative to the frame.
 14. A methodaccording to claim 13 wherein one of the plurality of needles isinserted through a needle support and into the spine while the needlesupport is in its first configuration, the needle has its dispositionchecked and corrected as necessary while the needle support is in itsfirst configuration, and then the needle support is reconfigured intoits second configuration while the needle remains inserted into thespine, with the foregoing process thereafter repeated for at least oneother of the plurality of needles.
 15. A method according to claim 14wherein the needle has its disposition checked and corrected asnecessary using fluoroscopy.
 16. A method according to claim 12 whereinthe frame comprises two frame supports connected to one another by atleast one adjustable arm.
 17. A method according to claim 16 whereineach of the frame supports comprises a frame lumen and a pair of slotscommunicating with the frame lumen.
 18. (canceled)
 19. (canceled)
 20. Amethod according to claim 16 wherein the frame supports are formed outof a radiolucent material, and further wherein radiopaque markers aredisposed on the frame supports.
 21. A method according to claim 12wherein the plurality of needle supports are formed out of a radiolucentmaterial, and further wherein radiopaque markers are disposed on theplurality of needle supports.
 22. A method according to claim 11 furthercomprising a spring-loaded syringe assist device for operating thesyringe.
 23. A delivery system for delivering a plurality of cannulateddevices into the anatomy of a patient, the delivery system comprising: aplurality of guidewires; a frame; and a plurality of guidewire supportsselectively movably mounted to the frame, wherein each of the guidewiresupports is configured to guide and hold a guidewire during insertioninto the anatomy of a patient; wherein the frame comprises two framesupports connected to one another by at least one adjustable arm;wherein each of the frame supports comprises a frame lumen and a pair ofslots communicating with the frame lumen; wherein each of the guidewiresupports comprises: a body slidably disposed in a frame lumen of a framesupport; and a member configured to slidably support a guidewire and toselectively lock the body in a selected position within a frame lumen ofa frame support.
 24. A method for delivering a plurality of cannulateddevices into the anatomy of a patient, the method comprising: providinga delivery system comprising: a plurality of guidewires; a frame; and aplurality of guidewire supports selectively movably mounted to theframe, wherein each of the guidewire supports is configured to guide andhold a guidewire during insertion into the anatomy of a patient; whereinthe frame comprises two frame supports connected to one another by atleast one adjustable arm; wherein each of the frame supports comprises aframe lumen and a pair of slots communicating with the frame lumen;wherein each of the guidewire supports comprises: a body slidablydisposed in a frame lumen of a frame support; and a member configured toslidably support a guidewire and to selectively lock the body in aselected position within a frame lumen of a frame support; positioningthe frame against the anatomy of the patient; using the plurality ofguidewire supports to guide the plurality of guidewires as they areinserted into the anatomy of the patient; withdrawing the frame and theplurality of guidewire supports while leaving the plurality ofguidewires inserted into the anatomy of the patient; and delivering aplurality of cannulated devices into the anatomy of a patient by passingthe cannulated devices over the plurality of guidewires.
 25. A needleguide for guiding and holding a plurality of needles during insertioninto a patient's body, the needle guide comprising: a frame; and aplurality of needle supports selectively movably mounted to the frame,wherein each of the needle supports is configured to guide and hold aneedle during insertion into the patient's body; and further whereineach of the needle supports is reconfigurable between: (i) a firstconfiguration wherein the needle support is movable at least one of (a)axially along the frame, and (b) rotatably relative to the frame; and(ii) a second configuration wherein the needle support is fixed relativeto the frame.
 26. A spring-loaded syringe assist device for use with asyringe containing a drug which is to be delivered into a patient'sspine, wherein the syringe comprises (a) a syringe body having a cavitycontaining the drug and an output port, and (b) a plunger movablydisposed in the cavity for driving the drug out of the output port, thespring-loaded syringe assist device comprising: a housing for mountingto the syringe body; a driver for engaging the plunger and moving theplunger so as to drive the drug contained in the cavity out of theoutput port; and a power unit for moving the driver.
 27. A portmultiplier comprising: a hollow body having an interior; an input portin fluid communication with the interior of the hollow body, the inputport being configured for attachment to a syringe containing a drug; anda plurality of output ports in fluid communication with the interior ofthe hollow body, each of the plurality of output ports being configuredfor attachment to a fluid line comprising a needle.